(26 days)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging.
The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.
The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
The provided FDA 510(k) summary for the DigiX FDX device details its substantial equivalence to predicate devices, particularly focusing on technical and functional similarities rather than a standalone performance study with specific acceptance criteria related to diagnostic accuracy. Therefore, the response will focus on the details available within the document regarding non-clinical testing and conformity to standards, as a direct "acceptance criteria vs. reported performance" table for diagnostic metrics is not present.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity for a particular condition) and a corresponding reported device performance with numerical results. Instead, the acceptance criteria are framed in terms of:
- Conformity to recognized standards: The device must comply with various IEC and ISO standards related to electrical safety, electromagnetic compatibility, radiation protection, software life cycle, usability, and risk management.
- Meeting design requirements: Non-clinical verification testing ensures the device's functions and image performance meet its design specifications.
- Substantial equivalence: The primary "acceptance criterion" for this 510(k) submission is to demonstrate substantial equivalence to the predicate devices (DigiX FDX K192541 and Siemens Ysio K081722) without raising new questions of safety or effectiveness.
| Acceptance Criteria Category | Reported Device Performance / Assessment |
|---|---|
| Safety Testing | Compliance with 21 CFR Federal Performance Standards (1020.30, 1020.31) and various FDA-recognized consensus standards (IEC 60601-1, 60601-1-2, 60601-1-3, 60601-2-54, 62304, 60601-1-6, 62366-1, ISO 14971, IEC 60825-1). Risk Analysis performed; risk control implemented to mitigate identified hazards. |
| Functional Testing | Functional testing of all motions of the system(s) with respect to design specifications. All functions met design requirements. |
| Image Performance | Image performance testing was conducted; results were included in the submission. Image performance criteria were met satisfactorily. |
| Software Verification | Software documentation for a Moderate Level of Concern software was included. Testing results support that all software specifications met acceptance criteria. Verification and Validation testing concluded no impact on safety and effectiveness from software updates. |
| Substantial Equivalence | Demonstrated by showing identical intended use, design principle, and applicable standards to the predicate and reference devices. Performance and non-clinical consideration results showed differences (e.g., appearance, user interfaces, physical dimensions, added detectors) do not raise new safety/effectiveness questions. |
| Dual Energy Subtraction | Marked as "Yes" for Subject Device, "No" for Predicate/Reference. This implies this new feature's performance and safety were evaluated to ensure it does not create new risks. |
2. Sample size used for the test set and the data provenance
The document explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Hence, clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. Bench testing was performed to assess the device safety and effectiveness."
Therefore, there was no "test set" in the sense of patient images or clinical data used for this 510(k) submission to prove diagnostic performance. The testing was non-clinical (bench testing, verification, and validation) and focused on engineering criteria, safety, and functionality.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring expert ground truth was used for this submission.
4. Adjudication method for the test set
Not applicable, as no clinical test set requiring adjudication was used for this submission.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. The DigiX FDX is an X-ray imaging system, not an AI-assisted diagnostic device for image interpretation. Its changes primarily involve hardware components (new detectors) and software GUI updates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is an X-ray system, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of diagnostic ground truth. For the non-clinical testing performed, the "ground truth" would be established by engineering specifications, recognized standards, and established testing methodologies for hardware and software functionality and safety.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that requires a training set for diagnostic classification.
9. How the ground truth for the training set was established
Not applicable.
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October 26, 2022
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Allengers Medical Systems Limited % Sanjeev Marjara Director Technical FDA Hall Unit-2, Bhankarpur, Mubarakpur Road Derabassi, Distt. Mohali, Punjab 140507 INDIA
Re: K223060
Trade/Device Name: DigiX FDX Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: September 20, 2022 Received: September 30, 2022
Dear Sanjeev Marjara:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name DigiX FDX
Indications for Use (Describe)
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or fixed or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D)☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Contact Person and Address
| Company Name: | Allengers Medical Systems Limited |
|---|---|
| Company Address: | FDA Hall, Unit-2, Bhankarpur, Mubarakpur Road, Derabassi,Distt Mohali-140507, India |
| Telephone No: | +91 1762-282600+919872980168rnd@allengers.net |
| Contact Person: | Sanjeev K. Marjara |
| Date Prepared: | 20.09.2022 |
2. Proposed Device:
| Device (trade) name: | DigiX FDX |
|---|---|
| Common/usual Name: | Digital X-Ray imaging system |
| Classification Name : | Stationary X-Ray system |
| Classification Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| 510(K) Submission: | Special |
3. Predicate Device:
| Device (trade) name: | DigiX FDX |
|---|---|
| Common/usual Name: | Digital X-Ray imaging system |
| Classification Name: | Stationary X-Ray system |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | KPR |
| 510(K) Number: | K192541 |
| Clearance Date: | October 16, 2019 |
4. Reference devices:
| Device (trade) name: | Ysio |
|---|---|
| Common/usual Name: | Digital X-Ray imaging system |
| Classification Name: | Stationary X-Ray system |
| Classification Panel: | Radiology |
| Regulation Number : | 21 CFR 892.1680 |
| Device Class : | Class II |
| Product Code: | KPR |
| 510(K) Number : | K081722 |
| Clearance Date : | August 25, 2008 |
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Allengers Medical Systems Ltd. Supplies Solid State X-Ray Image Detectors that have been previously cleared by FDA or tested and evaluated per guidance for submission of 510(K) for solid state X-Ray imaging devices. Table 1 provides the list of solid state detectors used with device.
| Solid State X-Ray Image Detectors | 510(K) Numbers |
|---|---|
| Fixed | |
| Varex PaxScan 4343R v3- Fixed | K172951 |
| Varex Paxscan 4343DXV - Fixed | K220311 |
| Varex Paxscan 4343RC - Fixed | K172951 |
| IRAY VENU 1717X – Fixed | K221714 |
| *IRAY Mercu 1717V3 - Fixed | -- |
| Allengers FP 4343R- Fixed | -- |
| *Allengers FP 4343RF- Fixed | -- |
| Varex (Perkin Elmer ) XRPAD 4343F- Fixed | K142698 |
| Wired/ Wireless | |
| InnoCare Yushan V17Ge (Wired) | K201528 |
| InnoCare Yushan V17Ce (Wired) | K220510 |
| Allengers G4343RG (Wired) | -- |
| Allengers G4343RC (Wired) | -- |
| InnoCare Yushan F14C (Wired/Wireless) | K210988 |
| InnoCare Yushan F14G (Wired/Wireless) | K210988 |
| InnoCare Yushan V14C (Wired/Wireless) | K201528 |
| InnoCare Yushan V14G (Wired/Wireless) | K201528 |
| InnoCare Yushan V17C (Wired/Wireless) | K201528 |
| InnoCare Yushan V17G (Wired/Wireless) | K201528 |
| Allengers G4336RWC (Wired/Wireless) | -- |
| Allengers G4336RWG (Wired/Wireless) | -- |
| Allengers G4343RWC (Wired/Wireless) | -- |
| Allengers G4343RWG (Wired/Wireless) | -- |
| Allengers T4336RWC (Wired/Wireless) | -- |
| Allengers T4336RWG (Wired/Wireless) | -- |
| Varex (Perkin Elmer) XRPAD 4336 – Wireless | K140551 |
| Varex PaxScan 4336W v4 + - Wireless | K192541 |
| Varex PaxScan 4343W – Wireless | K211423 |
| Varex Lumen 2530W – Wireless | -- |
| Varex Lumen 4336W – Wireless | -- |
| Varex Lumen 4343W – Wireless | -- |
| Thales Pixium 3543 DR-CS (Wireless) | K182517 |
| IRAY MARS 1417V (Wireless) | K192541 |
| IRAY MARS 1417X (Wireless) | K210316 |
| IRAY MARS 1717V (Wireless) | K201043 |
| *IRAY MARS 1717Vn (Wireless) | K201043 |
| IRAY MARS 1717X (Wireless) | K210314 |
| IRAY LUNA 1012X (Wireless) | K221345 |
| Allengers FP 4336RW (Wireless) | -- |
| Allengers FP 4343RW (Wireless) | -- |
| Allengers FP 4336RW-HR (Wireless) | -- |
| Allengers FP 4343RW-HR (Wireless) | -- |
| *Allengers FP 4343RW-DE (Wireless) | -- |
| Allengers FP 2430RW-FLX (Wireless) | -- |
Table 1 List of Solid State X-Ray Image Detectors
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Note: The Solid State X-Ray Image Detectors (Digital detectors) marked with "* can be used with Dual Energy Subtraction feature.
5. Device description:
The DigiX FDX system is a diagnostic X-Ray system intended for general purpose radiographic imaging of the human body. It is not intended for mammographic imaging.
The DigiX FDX system is comprised of a combination of devices that include a ceiling mounted X-Ray tube suspension, vertical Bucky stand, fixed or mobile patient Bucky table, X-Ray generator, X-Ray tube, beam limiting device, and a solid-state image receptor.
The DigiX FDX systems are not intended to be operated with any other cleared devices, or to be integrated with other software/hardware devices via direct or indirect connections.
The following in Table 2 are the specific components for various configurations of the system. A complete system will consist of a selection of one of the devices in each category.
| Component | Manufacture | Model |
|---|---|---|
| Ceiling Mounted X-Ray Tube Suspension | Allengers | CSA FDX |
| Vertical Bucky Stand | Allengers | VBS ADV |
| Vertical Bucky Stand | Allengers | VBS M XL |
| Patient Table - Fixed | Allengers | Floatex ADV |
| Patient Table - Fixed | Allengers | Floatex |
| Patient Table - Fixed | Allengers | Floatex XL |
| Patient Table - Mobile | Allengers | MobiT 6C |
| Patient Table - Mobile | Allengers | MobiT 4C |
| Patient Table - Mobile | Allengers | MobiT C |
| X-Ray Generator | Allengers | XGEN-80R |
| X-Ray Generator | Allengers | XGEN-65R |
| X-Ray Tube | Varex | A192 |
| X-Ray Tube | Varex | A292 |
| X-Ray Tube | Varex | G292 |
| X-Ray Tube | Varex | G1092 |
| X-Ray Tube | Varex | RAD14 |
| Beam Limiting Device | Ralco | R225 ACS |
| Solid State X-Ray Image Detector - Fixed | Varex | PaxScan 4343R v3 |
| Solid State X-Ray Image Detector - Fixed | Varex | Paxscan 4343DXV |
| Solid State X-Ray Image Detector – Fixed | Varex | Paxscan 4343RC |
| Solid State X-Ray Image Detector – Fixed | IRAY | VENU 1717X |
| Solid State X-Ray Image Detector – Fixed | IRAY | Mercu 1717V3 |
| Solid State X-Ray Image Detector – Fixed | Allengers | FP 4343R |
| Solid State X-Ray Image Detector – Fixed | Allengers | FP 4343RF |
| Solid State X-Ray Image Detector -Wired | Varex (Perkin Elmer) | XRPAD 4343F |
| Solid State X-Ray Image Detector – Wired | InnoCare | Yushan V17Ge |
| Solid State X-Ray Image Detector – Wired | InnoCare | Yushan V17Ce |
| Solid State X-Ray Image Detector – Wired | Allengers | G4343RG |
| Solid State X-Ray Image Detector – Wired | Allengers | G4343RC |
| Solid State X-Ray Image Detector – WiFi | Varex (Perkin Elmer) | XRPAD 4336 |
| Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4336W V4 + |
| Solid State X-Ray Image Detector – WiFi | Varex | PaxScan 4343W |
| Solid State X-Ray Image Detector – WiFi | Varex | Lumen 2530W |
| Solid State X-Ray Image Detector – WiFi | Varex | Lumen 4336W |
| Solid State X-Ray Image Detector – WiFi | Varex | Lumen 4343W |
| Solid State X-Ray Image Detector – WiFi | Thales | Pixium 3543DR-CS |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V14C |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V14G |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan F14C |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan F14G |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V17C |
| Solid State X-Ray Image Detector – WiFi/Wired | InnoCare | Yushan V17G |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1417V |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1417X |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717V |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717Vn |
| Solid State X-Ray Image Detector – WiFi | IRAY | MARS 1717X |
| Solid State X-Ray Image Detector – WiFi | IRAY | LUNA 1012X |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4336RW |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4336RW-HR |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW-HR |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 4343RW-DE |
| Solid State X-Ray Image Detector – WiFi | Allengers | FP 2430RW-FLX |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4336RWC |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4336RWG |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4343RWC |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | G4343RWG |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | T4336RWC |
| Solid State X-Ray Image Detector – WiFi/Wired | Allengers | T4336RWG |
| Image processing Software | e-Com | DROC |
| Image Processing Software | Allengers | Synergy DR FDX |
Table 2 Combination Details
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6. Indications for Use:
The DigiX FDX radiographic systems are used in hospitals, clinics and medical practices. DigiX FDX enables radiographic exposure of the whole body including: Skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma critical ill) applications.
Exposure may be taken with the Patient's sitting, standing, or in the prone/supine position.
The DigiX FDX System is not meant for mammography.
The DigiX FDX uses an integrated or portable or wi-fi digital detector for generating diagnostic images by converting X-Ray into electronics signals. DigiX FDX is also designed to be used with conventional film/screen or Computed Radiography (CR) Cassettes.
7. Technological Characteristics Comparison to Predicate & Reference Devices:
The Subject device DigiX FDX design is based on the Allenger's DigiX FDX (K192541) including the system control, Indication for use and mechanical design.
The modifications do not affect the intended use of the device the subject device and predicate device are based on the following same fundamental scientific technologies elements:
- . Energy emission to the patient - X-Ray
- Power requirement, Environmental requirement ●
- Mechanism to generate X-Ray .
- Mechanism to acquire, process and store image data ●
- Use of the hardware components ●
- Use of software processing ●
This 510(k) submission describes some modifications to the previously cleared predicate devices the DigiX FDX (K192541). The changes to the predicate DigiX FDX (K192541) include:
System Software Synergy DR FDX
- Graphical user interface (GUI): GUI of system software updated in order to ● improve the look and feel of user interface for better visibility & faster workflow.
- Updated to support all hardware modifications. Verification and Validation testing . concluded no impact on safety and effectiveness.
Component Change
- 25x30cm Wireless Detectors are added (Listed below), ●
- Lumen 2530W manufactured by Varex Imaging ●
- Luna 1012X manufactured by IRAY technology ●
- FP 2430RW-FLX manufactured by Allengers
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- 43x36cm Wired/Wireless Detectors are added (Listed below), ●
- Lumen 4336W manufactured by Varex Imaging ●
- MARS 1417X manufactured by IRAY technology. .
- Yushan V14C manufactured by InnoCare Optoelectronics. ●
- Yushan V14G manufactured by InnoCare Optoelectronics. ●
- Yushan F14C manufactured by InnoCare Optoelectronics. ●
- Yushan F14G manufactured by InnoCare Optoelectronics. ●
- FP 4336RW manufactured by Allengers
- FP 4336RW-HR manufactured by Allengers
- T4336RWC manufactured by Allengers ●
- T4336RWG manufactured by Allengers ●
- G4336RWC manufactured by Allengers ●
- G4336RWG manufactured by Allengers ●
- 43x43cm Wired/Wireless Detectors are added (Listed below), ●
- Paxscan 4343W manufactured by Varex imaging ●
- Lumen 4343W manufactured by Varex Imaging
- MARS 1717V manufactured by IRAY technology. ●
- MARS 1717Vn manufactured by IRAY technology. ●
- MARS 1717X manufactured by IRAY technology.
- Yushan V17C manufactured by InnoCare Optoelectronics. ●
- Yushan V17G manufactured by InnoCare Optoelectronics. ●
- Yushan V17Ge manufactured by InnoCare Optoelectronics.
- Yushan V17Ce manufactured by InnoCare Optoelectronics. ●
- FP 4343RW manufactured by Allengers ●
- . FP 4343RW-HR manufactured by Allengers
- FP 4343W-DE manufactured by Allengers ●
- G4343RWC manufactured by Allengers ●
- G4343RWG manufactured by Allengers ●
- G4343RG manufactured by Allengers .
- . G4343RC manufactured by Allengers
- 43x43cm Fixed Detectors are added (Listed below), .
- Paxscan 4343RC manufactured by Varex imaging ●
- Mercu 1717V3 manufactured by IRAY technology.
- . FP 4343R manufactured by Allengers
- FP 4343RF manufactured by Allengers ●
8. Software Feature
Synergy DR FDX imaging software manufactured by Allengers Medical systems Limited is a Digital Imaging System (DIS) provides useful functions to manage X-Ray images obtained from digital radiography system.
The software feature set and functions is essentially the same as the device, with the system complying with DICOM 3.0 specifications .Refer to 'Image processing and storage' in Section 13 (Page 5-0-10 to page 5-0-12) under table 4 of this document for a list of top level functions.
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9. Substantial Equivalence:
The DigiX FDX radiographic X-Ray system is substantially equivalent to the commercially available predicate Allenger's DigiX FDX Cleared October 16, 2019 with K192541 and Ysio (K081722).
Mechanical dimensions was slightly change, however the changes doesn't impact the intended use of device. Table 3 provides primary and secondary predicate comparable information.
| Predicate Device(s) Nameand Manufacture | 510(K)Number | Clearance Date | ComparableProperties |
|---|---|---|---|
| Predicate DeviceDigiX FDXProduct Code: KPRAddress: Allengers MedicalSystems Ltd. Bhankharpur,MubarakpurRoad, Derabassi, DisttMohali-140507 India | K192541 | 10/16/2019 | Technical Design Mechanical Design System Software |
| Reference Device: YsioProduct Code: KPRAddress: Siemens MedicalSolutions USA, Inc,51 valley stream, Parkway E-50, Malvern PA, 19335-1406 | K081722 | 8/25/2008 | Technical Design Mechanical Design System Software |
Table 3 Predicate Device Comparable Properties
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| Feature | DigiX FDX(Subject Device) | DigiX FDX(Predicate Device) | Siemens Ysio(Reference Device) | Justification fordifferences | ||
|---|---|---|---|---|---|---|
| 1. 510(k) | This submission | K192541 | K081722 | |||
| 2. Product Code | ||||||
| ProductClassificationCode | KPR | KPR | KPR | Same | ||
| 3. Product Classification | ||||||
| Classification | 21 CFR 892.1680 | 21 CFR 892.1680 | 21 CFR 892.1680 | Same | ||
| 4. Indication for Use | The DigiX FDX radiographicsystems are used inhospitals, clinics andmedical practices. DigiXFDX enables radiographicexposure of the whole bodyincluding: Skull, chest,abdomen, and extremitiesand may be used onpediatric, adult and bariatricpatients. It can also be usedfor intravenous, smallinterventions (like biopsy,punctures, etc.) andemergency (trauma criticalill) applications.Exposure may be taken withthe Patient's sitting,standing, or in theprone/supine position.The DigiX FDX System isnot meant formammography.The DigiX FDX uses anintegrated or portable orfixed or Wi-Fi digital detectorfor generating diagnosticimages by converting X-Rayinto electronics signals.DigiX FDX is also designedto be used with conventionalfilm/screen or ComputedRadiography (CR)Cassettes. | The DigiX FDXradiographic systems areused in hospitals, clinicsand medical practices.DigiX FDX enablesradiographic exposure ofthe whole body including:Skull, chest, abdomen,and extremities and maybe used on pediatric,adult and bariatricpatients. It can also beused for intravenous,small interventions (likebiopsy, punctures, etc.)and emergency (traumacritical ill) applications.Exposure may be takenwith the Patient's sitting,standing, or in theprone/supine position.The DigiX FDX System isnot meant formammography.The DigiX FDX uses anintegrated or portable orfixed or Wi-Fi digitaldetector for generatingdiagnostic images byconverting X-Ray intoelectronics signals. DigiXFDX is also designed tobe used withconventional film/screenor ComputedRadiography (CR)Cassettes. | The Ysio (New RADFamily) systems arethe radiographicsystems used inhospitals, clinics, andmedical practices.Ysio enablesradiographic andtomographicexposures of thewhole body including:skull, chest,abdomen, andextremities and maybe used on pediatric,adult and bariatricpatients. It can alsobe used forintravenous, smallinterventions (likebiopsy, punctures,etc.) and emergency(trauma, critical ill)applications.Exposures may betaken with the patientsitting, standing, or inthe prone position.The Ysio system isnot meant formammography. TheYsio uses anintegrated or portabledigital detector forgenerating diagnosticimages by convertingX-Rays into electronicsignals. Ysio is alsodesigned to be usedwith conventionalfilm/screen orComputedRadiography (CR)Cassettes | Essentially thesameNote: There arenodifferencesbetweenthe subject deviceand the predicatewith respect toindication andintended use. | ||
| Feature | DigiX FDX(Subject Device) | DigiX FDX(Predicate Device) | Siemens Ysio(Reference Device) | Justification fordifferences | ||
| 5. X-Ray Generator | ||||||
| Power | XGEN-80R : 80KW | XGEN-80R : 80KW | 80KW Standard | |||
| Rating (KW) | XGEN-65R : 65KW | XGEN-65R : 65KW | 65KW Optional | Same | ||
| kV minimum(65/80) | 40/40 kV | 40/40 kV | 40/40 kV | Same | ||
| kV maximum(65/80) | 150/150 kV | 150/150 kV | 150/150 kV | Same | ||
| mAmaximum @100kV(65/80) | 650/800 mA | 650/800 mA | 650/800 mA | Same | ||
| mAs Range(65/80) | 800/1000mAs | 800/1000mAs | NS | Same as predicatedevice | ||
| APRprogramming | Yes | Yes | Yes | Same | ||
| IR Remote | Yes | Yes | NA | Same aspredicate device | ||
| 6. X-Ray Tube | ||||||
| Make /Model | Varex Imaging/ G1092Varex Imaging/ G292Varex Imaging/ A292Varex Imaging/ A192Varex Imaging/RAD14 | Varex Imaging/G1092Varex Imaging/ G292Varex Imaging/ A292Varex Imaging/ A192Varex Imaging/RAD14 | Siemens OPTITOPSiemens OPTILIX | Same asPredicate Device | ||
| 7. Solid State X-Ray Image Detectors | ||||||
| Varex's PaxScan 4343R v3Varex's PaxScan 4343DXVVarex's, Paxscan 4343RCIray, VENU 1717XIray, Mercu 1717V3Allengers, FP 4343RAllengers, FP 4343RFInnoCare's, Yushan V17CeInnoCare's,Yushan V17GeAllengers, G4343RCAllengers, G4343RG | Varex's PaxScan 4343Rv3Varex's, Paxscan4343CBIray, VENU 1717X | Trixell Pixium 4600 | Additional Solidstate X-RayImage detectorsfrom the predicatecan be used withthe system. Thesystem has beentested and thereis "No negativeimpact on safetyor efficacy" .There is no newpotential orincreased safetyrisks concerningwere raisedbecause of thisdifference. | |||
| Make /Model | Varex's, XRPAD 4343 FVarex's, XRPAD 4336Varex's PaxScan 4336Wv4+Varex's PaxScan 4343WVarex's Lumen 2530WVarex's Lumen 4336WVarex's Lumen 4343WThales Pixium 3543 DR-CSInnoCare's,Yushan F14CInnoCare's,Yushan F14GInnoCare's,Yushan V14CInnoCare's,Yushan V14GInnoCare's,Yushan V17CInnoCare's,Yushan V17GIray, MARS 1417VIray, MARS 1417XIray's MARS 1717VIray, MARS 1717Vn | Varex's, XRPAD 4343 FVarex's, XRPAD 4336Varex's PaxScan 4336Wv4 +Varex's PaxScan 4336WVarex's PaxScan 4336WV4Thales Pixium 3543 DR-CSIray, MARS 1417V | Trixell Pixium 4600Thales Pixium 3543 | |||
| Feature | DigiX FDX(Subject Device) | DigiX FDX(Predicate Device) | Siemens Ysio(Reference Device) | Justification fordifferences | ||
| Iray's MARS 1717XIray's Luna 1012XAllengers, FP 4336RWAllengers, FP 4343RWAllengers, FP 4336RW-HRAllengers, FP 4343RW-HRAllengers, FP 4343RW-DEAllengers, FP 2430RW-FLXAllengers, G4336RWCAllengers, G4336RWGAllengers, G4343RWCAllengers, G4343RWGAllengers, T4336RWCAllengers, T4336RWG | ||||||
| 8. Ceiling Mounted X-Ray Tube Suspension | ||||||
| Model | CSA FDX | CSA FDX | Ysio | Same asPredicate device | ||
| 9. Vertical Bucky Stand | ||||||
| Model | VBS ADVVBS M XL | VBS ADVVBS M XL | BWS with Max staticBWS wi-D | Same asPredicate device | ||
| 10. Patient Table | ||||||
| Model | Floatex XLFloatex ADVFloatexMobiT 6CMobiT 4CMobit C | Floatex XLFloatex ADVFloatexMobiT 6CMobiT 4CMobit C | Bucky Table | Same asPredicate device | ||
| 11. Beam Limiting Device | ||||||
| Construction | Multi-leaf | Multi-leaf | Multi-leaf | Same | ||
| CFR 211020.31 | Compliant | Compliant | Compliant | Same | ||
| Automatic | Yes | Yes | Yes | Same | ||
| 12. Viewing Monitors | ||||||
| Monitor(minimumSize) | 19 inch or more (Touch andNon Touch) | 19 inch or more (Touchand Non Touch) | 19 inch Monitor | Same asPredicate device | ||
| 13. Image Processing and storage | ||||||
| Model | Synergy DRFDX | DROC | DelWorks DRSystem | -- | ||
| FDA Cleared | -- | K130883 | Yes, K140825 | -- | ||
| OperatingSystem | MicrosoftWindows7/MicrosoftWindow 10 | MicrosoftWindows7/MicrosoftWindow 10 | Microsoft Windows7 | Same asPredicate device | ||
| Network | Ethernet/ Wifi | Ethernet/Wifi | Ethernet/ Wifi | Same | ||
| User | Mouse,Keyboard, | Mouse,Keyboard | Mouse, Keyboard, | Same | ||
| Interaction | Touch | Touch | Touch Monitor | Same | ||
| Feature | DigiX FDX(Subject Device) | DigiX FDX(Predicate Device) | Siemens Ysio(Reference Device) | Justification fordifferences | ||
| /input | Monitor, | Monitor, | Monitor, | Monitor, | Available | |
| Multi-user | Available | Available | Available | Available | Available | Same |
| Import/Export images | Yes | Yes | Yes | Yes | Yes | Same |
| Acquisitiondevice | ComputedRadiographyDigital X-RayDetector | ComputedRadiography Digital X-RayDetector | ComputedRadiographyDigital X-RayDetector | ComputedRadiographyDigital X-RayDetector | ComputedRadiography DigitalX-Ray Detector | Same |
| ImageInterferences | Detectordependent | Detectordependent | Detectordependent | Detectordependent | Detector dependent | Same |
| ImageOrganization | YesPatientID / Name/Age / DOB/Studyinstance UID | YesPatientID / Name/Age /DOB/ StudyinstanceUID | YesPatientID /Name/Age /DOB/StudyinstanceUID | YesPatientID / Name/Age / DOB/Studyinstance UID | YesPatient ID / Name/Age / DOB/ Studyinstance UID | Same |
| ImageSearchavailable | Yes | Yes | Yes | Yes | Yes | Same |
| ImageStorage | Yes | Yes | Yes | Yes | Yes | Same |
| Databasestorage | Yes | Yes | Yes | Yes | Yes | Same |
| DatabaseSoftware | MS-Access | MS-Access | MS-Access | MS-Access | MS-Access | Same |
| ImageViewing | Yes | Yes | Yes | Yes | Yes | Same |
| Imagemeasurement | Yes | Yes | Yes | Yes | Yes | Same |
| ImageAnnotation | Yes | Yes | Yes | Yes | Yes | Same |
| ImageOperation | Yes | Yes | Yes | Yes | Yes | Same |
| ImageStitching | Automatic | Manual | Automatic | Manual | Manual | Same asPredicate device |
| DICOM 3.0Compatibility | Yes | Yes | Yes | Yes | Yes | Same |
| GeneratorControl | Yes | Yes | Yes | Yes | Yes | Same |
| GeneratorControlProtocols | Generator dependent | Generator dependent | Same |
Table 4: Functional and specification differences
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| Feature | DigiX FDX(Subject Device) | DigiX FDX(Predicate Device) | Siemens Ysio(Reference Device) | Justification fordifferences |
|---|---|---|---|---|
| Raw imageDataProcessing | Yes | Yes | Yes | Same |
| Post imagedataprocessing | Yes | Yes | Yes | Same |
| RIS codemanager | Yes | Yes | Yes | Same |
| Dual EnergySubtraction | Yes | No | No | Same asPredicate device |
| 14. Power Requirement | ||||
| PowerRequirement | 400 VAC ,(±10% ) 50/60 Hz | 400 VAC,(±10%) 50/60 Hz | 400 VAC,(±10%)50/60 Hz | Same |
| 15. Biological Characteristics | ||||
| Table TopMaterial | Carbon Composite Material | Carbon CompositeMaterial | Carbon CompositeMaterial | Same |
10. Reason for Submission
Modification of cleared device
11. Description of Non Clinical & Clinical testing
Non-clinical testing included verification and validation testing, image evaluation, testing, and safety testing. Risk Analysis was performed on the entire system.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Allengers certify conformance to Voluntary Standards covering Electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Safety Information:
This system demonstrates compliance with the following 21 CFR Federal Performance Standards:
- 1020.30 Diagnostic X-Ray Systems and their major components .
- 1020.31 Radiographic equipment ●
and with the following relevant voluntary FDA Recognized Consensus Standards as listed in the table below:
| RecognitionNumber | ProductArea | Title of standard | ReferenceNumber anddate | StandardDevelopmentorganization |
|---|---|---|---|---|
| 19-4 | General | Medical Electrical Equipment -Part 1: General requirements forbasic safety and essentialperformance | 60601-1:2012,ed. 3.1 | IEC |
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| 19-8 | General | Medical electrical equipment - Part1-2: General requirements for basicsafety and essential performance –Collateral Standard:Electromagnetic Compatibility –Requirements and tests | 60601-1-2Edition 4.02014-02 | IEC |
|---|---|---|---|---|
| 12-269 | Radiology | Medical Electrical Equipment Part1-3: General Requirements forBasic Safety and EssentialPerformance.-Collateral Standard:Radiation Protection in DiagnosticX-Ray Equipment. | 60601-1-3Edition 2.12013-04 | IEC |
| 12-296 | Radiology | Medical Electrical Equipment- Part2-54: Particular Requirements forthe Basic Safety and EssentialPerformance of X-Ray Equipmentfor Radiography and Radioscopy | 60601-2-54,(Edition 1.12015). | IEC |
| 13-79 | General | Medical device software - Softwarelife cycle processes | 62304 (Edition1.1, 2015) | IEC |
| 5-89 | General | Medical Electrical Equipment Part1-6: General Requirements forBasic Safety and EssentialPerformance- Collateral Standard:Usability | 60601-1-6,(Edition 3.12013). | IEC |
| 5-114 | General | Application of Usability Engineeringto Medical Devices | 62366-1 Edition1.0 2015-02 | IEC |
| 5-125 | General I(QS/RM) | Medical devices - application ofrisk management to medicaldevices | 14971 ThirdEdition 2019-12 | ISO |
| 12-273 | Radiology | Safety of laser products - Part 1:Equipment classification, andrequirements | 60825-1 Edition2.02007-03 | IEC |
Table 4: FDA Guidance Documents
| FDA Guidance Documents and Effective Date | |
|---|---|
| 1 | Guidance for Industry and FDA Staff – User Fees and Refunds for PremarketNotification Submissions 510(k)Document issued on October 2, 2017 |
| 2 | Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policyfor 510(k)sDocument issued on April 21, 2022. |
| 3 | Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s -Guidance for Industry and FDA StaffDocument issued on September 13, 2019. |
| 4 | Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program:Evaluating Substantial Equivalence in Premarket Notifications [510(k)]Document Issued on July 28, 2014 |
| 5 | Guidance for Industry and FDA Staff: Guidance for the Submission Of 510(k)'s for SolidState X-ray Imaging DevicesDocument issued on September 1, 2016 |
| 6 | Guidance for Industry and FDA Staff: Guidance for the Content of PremarketSubmission for Software in Medical DevicesDocument issued on May 11, 2005 |
| 7 | Guidance for Industry and FDA Staff: Guidance for Off-The-Shelf Software Use inMedical DevicesDocument issued on September 27, 2019 |
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| 8 | Guidance for Industry and FDA Staff: Applying Human Factors and UsabilityEngineering to Medical Devices.Document issued February 3, 2016 |
|---|---|
| 9 | Guidance for Industry and FDA Staff: Pediatric Information for X-ray Imaging DevicePremarket Notifications.Document issued on November 28, 2017 |
| 10 | Guidance for Industry and FDA Staff: Content of Premarket Submissions formanagement of Cybersecurity in Medical devices.Document issued on October 2, 2014 |
| 11 | Guidance for Industry and FDA Staff: Electromagnetic Compatibility (EMC) of MedicalDevicesDocument issued on June 6, 2022 |
Performance Testing:
Performance testing included functional testing of all motions of the system(s) with respect to the design specifications. Image performance testing was conducted and results included in the submission. All functions met the design requirements and the image performance criteria satisfactorily.
Non-clinical verification test results demonstrate that the Digital Radiographic system complies with the aforementional and FDA recognized consensus standards and FDA guidance documents. Also No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed device. Hence, clinical testing is not applicable due to the fact that no new clinical applications were introduced to the system. Bench testing was performed to assess the device safety and effectiveness.
12. Substantial Equivalence Conclusion:
DigiX FDX, Digital Radiography System does not introduce any new indications for use, nor does the use of the systems result in any new potential hazards. The subject device is substantially equivalent to the DigiX FDX (K192541) and Ysio (K081722) . The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate & reference device. Some characteristics, for example, their appearance, the user interfaces and the physical dimensions are different. However, the performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the Allengers opinion that the subject device appears to be as safe and effective as the predicate & reference device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.